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L'essai clinique NCT05564936 pour Myasthénie Grave est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
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L'étude clinique NCT05564936 est un essai interventionnel pour Myasthénie Grave. Son statut actuel est : en recrutement. L'étude a débuté le 24 janvier 2024 et vise à recruter 144 participants. Dirigé par Ad scientiam, l'essai devrait être terminé d'ici le 24 septembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 11 avril 2025.
Résumé succinct
ME&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
ME&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Description détaillée
Myasthenia gravis (MG) is an autoimmune neuromuscular disease characterised by fatigable muscle weakness due to autoantibodies targeting components of the neuromuscular junction.
Deficits are measured using validated clinical scales such as the Quantitative Myasthenia Gravis score (QMG) QMG, Myasthenia Gravis Composite Score (MCS), Myasthenia Gravis Activities of Daily Living score (MG-ADL), etc., Unfortunately, this type of assessment might require expensive material, time, and personnel training, which make MG assessment difficult for clinicians in routine care.
Research on the matter has highlighted the importance of Patient-Reported Outcomes (PROs), composite measures of disease severity and quality-of-life measurements. This has led to the development of a number of tools for the self-assessment of PROs with validated questionnaires. However, there is no tool that overcomes the constraints of standard tests such as the QMG while allowing for the collection of objective data and PROs between visits.
ME&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
ME&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Titre officiel
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study
Conditions
Myasthénie GraveAutres identifiants de l'essai
- DOMYA
Numéro NCT
Date de début (réel)
2024-01-24
Dernière mise à jour publiée
2025-04-11
Date de fin (estimée)
2026-09-24
Inscription (estimée)
144
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Autre
Plan d'attribution
Non aléatoire
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalMG patients MG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months | ME&MG Mobile Application ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. |
AutreHealthy volunteers Healthy volunteers will perform one in-clinic visit and will use the app at-home once | ME&MG Mobile Application ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions | Pearson correlation coefficient will be used to assess the relationship between digital tests versus standard tests | baseline |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
To compare results between in-clinic digital tests and in-clinic standard tests, test to test | pearson correlation coefficient between digital tests and standard tests | baseline |
To assess reproducibility between in-clinic digital tests and at-home digital tests | intraclass correlation coefficient | baseline, day 1, day 89, day 90 |
To assess test-retest reliability of at-home digital tests | intraclass correlation coefficient mean k raters (ICCk; k=day) | Day1, Day 2, Day 3, Day 87, Day 88, Day 89 |
To compare results obtained with the at-home ME&MG composite score and the in-clinic standard QMG composite score | Pearson correlation coefficient between digital composite score and QMG score | baseline, day 1 |
To assess adverse events related to the use of the mobile application | Descriptive analysis of adverse events (AEs) related to the use of the application | through study completion, an average of 1 year |
To assess satisfaction and user experience with the smartphone application | descriptive analysis of questionnaires resulsts | through study completion, an average of 1 year |
To assess correlation of the at-home ME&MG composite score with the Myasthenia Gravis Activities of Daily Living (MG-ADL) score | Pearson's correlation coefficient between ME\&MG composite score and MG-ADL scores | baseline, day 90, day 365 |
to assess daily activites | Myasthenia Gravis Activities of Daily Living (MG-ADL) | 12 months |
to assess depression | Patient Health Questionnaire-8 (PHQ8) | 12 months |
to assess pain | pain likert scale | 12 months |
to assess insomnia | Insomnia Severity Index | 12 months |
To assess at-home compliance to the ME&MG smartphone application | descriptive analysis of adherence data | through study completion, an average of 1 year |
To assess quality of life | 36-Item Short Form Survey (SF-36) | Baseline, day 90, Day 365 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- Aged over 18 Years
- Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator
- With positive serologic testing for anti-AChR autoantibody at screening
- Have read the information sheet and signed the informed consent form
- Own a personal smartphone which software version is above 13 for IOS and 8 for Android included
- Able to use a smartphone
- Able to read language in which the mobile application is available (French, English, Spanish) and able to understand pictograms
- Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening
- Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening
- Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
- Pregnant and nursing women
- Person under guardianship or curatorship
- Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
- Participant included in another ME&MG clinical study
- Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study.
Ad scientiamContact central de l'essai
Contact: Pr Laforet, +33147107752, [email protected]
19 Centres de l'essai dans 2 pays
Hôpital Raymond Poincaré, Garches, 92380, France
Pr Pascal Laforet, Contact, 01.47.10.77.36, [email protected]
Dr Edouard Berling, Investigateur principal
Dr Claire LEFEUVRE, Investigateur associé
Dr Alice ROUYER, Investigateur associé
Pr Guillaume NICOLAS, Investigateur associé
En recrutement
CHU Grenoble, Grenoble, France
Dr Lagrange, Contact, +33 476767575, [email protected]
Dr Lagrange, Investigateur principal
Pas encore en recrutement
Hôpital Salengro, Lille, France
Dr Tard, Contact, +33 3 20 44 59 62, [email protected]
Dr Tard, Investigateur principal
En recrutement
CHRU Nancy, Nancy, 54035, France
Dr Michaud, Contact, +33 3 83 85 85 85, [email protected]
Dr Michaud, Investigateur principal
Pauline DUCATEL, Investigateur associé
En recrutement
CHU Nantes, Nantes, France
Dr Péréon, Contact, +33 0240083617, [email protected]
Dr Péréon, Investigateur principal
En recrutement
Pitié-Salpêtrière, Paris, 75013, France
Anthony Behin, Dr, Contact, +33 142163774, [email protected]
Anthony Behin, Dr, Investigateur principal
Tanya STOJKOVIC, Dr, Investigateur associé
En recrutement
CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg, 67200, France
Terminé
CHU Toulouse, Toulouse, France
Dr Cintas, Contact, +33 5 61 77 94 40, [email protected]
Dr Cintas, Investigateur principal
En recrutement
Colorado
University of Colorado Denver, Aurora, Colorado, 80204, United States
Thomas Ragole, Dr, Contact, 303-724-2188, [email protected]
Dr Ragole, Investigateur principal
En recrutement
Florida
University of Florida Health, Jacksonville, Florida, 32209, United States
Michael T Pulley, Contact, (904) 383-1022, [email protected]
En recrutement
Indiana
HealthParterns Institute, Bloomington, Indiana, 47401, United States
Terminé
Indiana University Health, Indianapolis, Indiana, 46123, United States
Sara M Takacs, Contact, 3179485450, [email protected]
En recrutement
Kentucky
University of Kentucky, Lexington, Kentucky, 40536, United States
Ima M Ebong, Contact, 8592571000, [email protected]
En recrutement
New York
Neurological Associates of Long Island, P.C., Lake Success, New York, 11042, United States
Denis Ostrovskiy, MD, Contact, (516) 466-4700, [email protected]
En recrutement
North Carolina
Duke University, Durham, North Carolina, 27708, United States
Shruti Raja, Dr, Contact, 919-684-5422, [email protected]
Dr Raja, Investigateur principal
En recrutement
Oregon
OHSU, Portland, Oregon, 97239, United States
Nizar Chahin, Dr, Contact, 503-494-7772, [email protected]
Dr Chahin, Investigateur principal
En recrutement
Pennsylvania
Thomas Jefferson University, Philadelphia, Pennsylvania, 19144, United States
Erika Wong, Dr, Contact, 215 955-4672, [email protected]
Dr Wong, Investigateur principal
En recrutement
Tennessee
The University of Tennessee Medical Center, Knoxville, Tennessee, 37920, United States
Christopher Dr Scheiner, Contact, 856-521-6174, [email protected]
Dr Scheiner, Investigateur principal
Pas encore en recrutement
Vanderbilt Health, Nashville, Tennessee, 37232, United States
Lindsay Malatesta, Dr, Contact, 615 936-0600, [email protected]
Dr Malatesta, Investigateur principal
En recrutement